ID

35861

Description

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Solicited adverse events - local and general symptoms and Unsolicited AE form. It has to be filled in for Visit 1 and Visit 3.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Keywords

Versions (2)
  1. 3/25/19 3/25/19 -
  2. 3/29/19 3/29/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 29, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

English

Solicited adverse events - local and general symptoms, Unsolicited AE

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Solicited adverse events - local symptoms
Description

Solicited adverse events - local symptoms

Alias
UMLS CUI-1
C1517001
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0042196
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2368628
Local symptoms
Description

Local symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Presence of symptom
Description

Tick for each symptom

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Day after Vaccination
Description

Please tick intensity for each local symptom for every day.

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Size of symptom
Description

Fill in for each redness and swelling/induration.

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0518690
mm
Intensity of Pain
Description

Pain at injection site: Grade 0: None Grade 1: Pain on touching the site, not otherwise. Grade 2: Pain on moving the limb which interferes with normal activities or requires repeated use of pain relievers Grade 3: Significant pain at rest; prevents normal activities as asses

Data type

integer

Alias
UMLS CUI [1]
C1320357
Ongoing after Day 6?
Description

Local Symptom ongoing

Data type

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited adverse events - general symptoms
Description

Solicited adverse events - general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2368628
General symptom
Description

General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
Presence of symptom
Description

Tick for each symptom

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0150312
Day after Vaccination
Description

Fill in for each symptom. If you ticked "Temperature" as symptom, note the body temperature of subject for each day. If you do not measure tick "not taken".

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
If you tick "Temperature" as symptom, please note the route of measurement.
Description

If you don't take body temperature, please tick "not taken".

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Body temperature
Description

Temperature to be reported: Axillary >= 37.5°C, >= 99.5°F Oral >= 37.5°C, >= 99.5° Rectal >= 38.0°C, >= 100.4°F

Data type

float

Alias
UMLS CUI [1]
C0005903
Body temperature, Unit
Description

Body temperature, Unit

Data type

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Intensity of symptom
Description

Fill in for each: Fatigue, Headache, Joint pain, Muscle aches, Shivering, sweating increase. Definition: Grade 0: None Grade 1: No effect on normal activities Grade 2: Some interference with normal everyday activities or (for headache, joint or muscle pain) requires repeated use of pain relievers Grade 3: Prevents normal everyday activities as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider

Data type

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 6?
Description

Symptom ongoing

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0159028
Causality of symptom?
Description

Causality of symptom

Data type

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1457887
Unsolicited Adverse events
Description

Unsolicited Adverse events

Alias
UMLS CUI-1
C4055646
UMLS CUI-2
C0877248
UMLS CUI-3
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events including new onset chronic diseases?
Description

If you tick yes, fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. Timepoints: For Dose 1 (Visit 1): between Visit "Day 0" through Visit "Day 21". For Dose 2 (Visit 3): between Visit "Day 21" through Visit "Day 42"

Data type

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0008679
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Similar models

Solicited adverse events - local and general symptoms, Unsolicited AE

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 3 (2)
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Solicited adverse events - local symptoms
C1517001 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0042196 (UMLS CUI-4)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Signs and symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
Local symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms: Redness
Code List
Local symptoms
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Pain (PA)
Item
Presence of symptom
text
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Presence of symptom
Code List
Presence of symptom
CL Item
Yes (Y)
CL Item
No (N)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Day of symptom duration
Code List
Day after Vaccination
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3  (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Size of symptom
Item
Size of symptom
integer
C0456389 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Item
Intensity of Pain
integer
C1320357 (UMLS CUI [1])
Local symptoms: Redness
Code List
Intensity of Pain
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item
Ongoing after Day 6?
text
C0549178 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Symptom ongoing
Code List
Ongoing after Day 6?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Solicited adverse events - general symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Signs and symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
General symptom
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
General symptom
Code List
General symptom
CL Item
Temperature (TE)
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Joint pain (JO)
CL Item
Muscle aches (MH)
CL Item
Shivering (SH)
CL Item
Sweating increase (SE)
Item
Presence of symptom
text
C0159028 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Presence of symptom
Code List
Presence of symptom
CL Item
Yes (Y)
CL Item
No (N)
Item
Day after Vaccination
text
C0439228 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Day of symptom duration
Code List
Day after Vaccination
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3  (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
CL Item
Not taken (X)
Item
If you tick "Temperature" as symptom, please note the route of measurement.
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Body temperature
Code List
If you tick "Temperature" as symptom, please note the route of measurement.
CL Item
Axillary (A)
CL Item
Oral (mandatory) (O)
CL Item
Rectal (R)
CL Item
Not taken (NT)
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Body temperature, Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body temperature, Unit
Code List
Body temperature, Unit
CL Item
°C (1)
CL Item
°F (2)
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item
Ongoing after Day 6?
text
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom ongoing
Code List
Ongoing after Day 6?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Item
Causality of symptom?
text
C0015127 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Causality of symptom
Code List
Causality of symptom?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Unsolicited Adverse events
C4055646 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events including new onset chronic diseases?
text
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0008679 (UMLS CUI [3])
SAE/AE, chronic disease
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events including new onset chronic diseases?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
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